Official Title: “Randomized, Double-Blind, Multi-Centre, Parallel-Goup Study to Investigate the Efficacy and Safety of Three Doses of Bay 38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction”

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Vardenafil (Levitra, BAY38-9456)
  • 5 mg Vardenafil orally 1 hour prior to sexual intercourse
• Drug: Vardenafil (Levitra, BAY38-9456)
  • 10 mg Vardenafil orally 1 hour prior to sexual intercourse
• Drug: Vardenafil (Levitra, BAY38-9456)
  • 20 mg Vardenafil orally 1 hour prior to sexual intercourse
• Drug: Placebo
  • 5 mg matching placebo
• Drug: Placebo
  • 10 mg matching placebo
• Drug: Placebo
  • 20 mg matching placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a
• Experimental: Arm 2
  • n/a
• Experimental: Arm 3
  • n/a
• Placebo Comparator: Arm 4
  • n/a
• Placebo Comparator: Arm 5
  • n/a
• Placebo Comparator: Arm 6
  • n/a

Primary Measures

• Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Global Assessment Questionnaire
  • Time Frame: 12 weeks
    Safety Issue?: No
• Erectile Function domain score of the International Index of Erectile Function
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
• Stable heterosexual relationship

Exclusion Criteria:

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
• Nitrate use
• Other exclusion criteria apply

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 22 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668057

Study ID Number: 10690

ClinicalTrials.gov Identifier: NCT00668057

Health Authority: China: State Food and Drug Administration

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